A Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of VRT106 in Combination With Chemotherapy for Resectable Pancreatic Cancer

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangdong Provincial People's Hospital

About this trial

This is a single-center, single-arm, open investigator-initiated clinical study to evaluate the efficacy and safety of VRT106 in combination with chemotherapy in the treatment of resectable pancreatic cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject voluntarily agrees to participate in this study and signs an Institutional Review Board -approved informed consent prior to performing any of the Screening Visit procedures.

Males and females at 18-75 years of age, inclusive, at the Screening Visit.

Have a clinical diagnosis of pancreatic cancer.

An Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.

Disqualifiers

Prior treatment with other oncolytic virus or systemic therapy for pancreatic cancer.

Previous allogeneic hematopoietic stem cell transplantation or organ transplantation.

Immunocompromised patients.

Known alcohol or drug dependency.

Trial design

Design model

Single group

Treatments tested in this trial

  • Oncolytic virus VRT106

    Drug

    VRT106, IV

  • Chemotherapy

    Drug

    21 days/cycle, administered up to 6 cycles

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: VRT106 combination with chemotherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Safety and tolerability

Incidence rate of TRAE(Treatment-Related Adverse Event)

Time frame
About 3 years

Secondary outcomes

1

Disease-free survival rate

Disease-free survival rates at 6, 12, 18, and 24 months

Time frame
About 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangdong Provincial People's Hospital

Lead sponsor

Guangzhou Virotech Pharmaceutical Co., Ltd.

Collaborator